Low-dose Atropine for the Prevention of Myopia Progression in Danish Children - a Randomized, Double-masked, Multicenter, 36-month Prospective 1:1:1 Study of Safety and Efficacy of 0.1% Atropine Loading Dose to Single 0.01% Atropine and Placebo

Who is this study for? Danish children with myopia
Status: Active, not recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Myopia (nearsightedness) is increasing in prevalence throughout the world. It is associated with a risk of potentially blinding complications such as retinal detachment and myopic maculopathy. There is a direct association between the degree of myopia and the risk of complications. Myopia develops in childhood and during adolescence. To prevent higher degrees of myopia, we need to halt disease progression in children and teenagers. Low-dose atropine eye drops have been shown to reduce myopia progression by 50% in Asian populations but its effect in non-Asian populations is unknown. The aim of this study is to investigate if low-dose atropine can reduce myopia progression in Danish children and teenagers. The study is an investigator initiated randomized clinical trial conducted as a collaboration between three Danish Eye Departments covering all of Denmark.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 12
Healthy Volunteers: No
View:

• Children aged ≥6-<9 years: myopia ≤-1 (spherical power) in at least one eye

• Cylinder less than 1.5 diopters

Locations
Other Locations
Denmark
Department of Ophthalmology, Aarhus University Hospital
Aarhus
Department of Ophthalmology, Rigshospitalet-Glostrup
Glostrup
Department of Ophthalmology, Vejle Hospital
Vejle
Time Frame
Start Date: May 30, 2019
Estimated Completion Date: December 2024
Participants
Target number of participants: 97
Treatments
Experimental: Loading dose
In phase 1 (treatment phase), the participants (n=50) will receive 0.1% atropine loading dose for 6 months followed by 0.01 % atropine for 18 months. The eye drops are administered as one eye drop daily in each eye at bedtime.~In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.
Experimental: Low dose
In phase 1 (treatment phase), the participants (n=50) will receive 0.01 % atropine for 24 months. The eye drops are administered as one eye drop daily in each eye at bedtime.~In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.
Placebo Comparator: Placebo
In phase 1 (treatment phase), the participants (n=50) will receive placebo eye drops for 24 months. The eye drops are administered as one eye drop daily in each eye at bedtime.~In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.
Authors
Fifa Björnsson, Hanne Hauge Ladegaard, Rikke Kroman Nørby, Anders Hvid-Hansen, Flemming Møller, Bettina Lehrmann, Jesper Hjortdal, Toke Bek, Dorte Larsen, Line Kessel, NIna Jacobsen
Related Therapeutic Areas
Sponsors
Collaborators: Vejle Hospital, Aarhus University Hospital
Leads: Line Kessel

This content was sourced from clinicaltrials.gov

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